Ovarian Cancer Clinical Trial
Official title:
Nudge to Referral of Adnexal Masses to Gynecologic Oncology
Verified date | June 2024 |
Source | Abramson Cancer Center at Penn Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | May 31, 2025 |
Est. primary completion date | April 24, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women ages 18 years or older - Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician Exclusion Criteria: - Known diagnosis of ovarian cancer - Patient already established in gynecologic oncology |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adoption | The primary implementation outcome is adoption, operationalized as the proportion of patients who are referred to gynecologic oncology within 30 days of diagnosis by study arm, to be evaluated overall and for historically marginalized patients. | 30 days | |
Secondary | Gyn Onc Visits | The proportion of patients completing gynecologic oncology visits for surgical evaluation. | 90 days | |
Secondary | Gyn Onc Visits | Time to first gynecologic oncology visit (in days from radiologic or pathologic diagnosis), also to be evaluated overall and for historically marginalized patients. | 90 days | |
Secondary | Adherence to Treatment | Adherence to evidence-based treatment within 365 days of patient follow-up. | 365 days | |
Secondary | Progression Free and Overall Survival | Progression-free and overall survival within 365 days of patient follow-up. | 365 days |
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